A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas

Phase 2

Recruiting

• Conditions: Cancer of Pancreas
• Interventions: Other: follow up; Drug: Capecitabine

• Registration Number: NCT05566743
• Lead Sponsor: Menoufia University

Brief Summary

A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.

Detailed Description

In this study, we aim to evaluate the role of maintenance capecitabine by comparing 2 arms of metastatic cancer pancreas patients in the first line , the first arm will receive 4 months of induction FOLFRINOX the maintenance capecitabine and the second arm will receive 4 months of FOLFRINOX then kept under follow-up:

•Primary end point: PFS.

•Secondary end points: OS, QOL and Toxicity.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-11
• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-30
• Last Update Submitted: 2022-09-30
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Primary Completion: 2023-09-11
• Study Completion: 2024-09-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologically confirmed invasive adenocarcinoma of pancreas.
• Stage 4 disease according to The American Joint Committee on Cancer (AJCC the 8th Edition) 2017.
• Measurable metastases according to RECIST 1.1.
• Patients underwent surgical resection and postoperative evaluation revealed distant metastasis.
• Patients with age ranging from 18 to 69.
• WHO performance status 0-1.
• An adequate bone marrow reserve and adequate liver and renal function as follow: Neutrophils ≥ 1500 cell/dl, Platelets ≥ 100,000 cell/dl, Hemoglobin ≥ 9.0 g/dl, Total bilirubin < 1.5 × upper normal level (UNL), SGOT and SGPT < 3 × UNL, Creatinine < 1.5 × UNL or estimated GFR > 30 ml/min.
• Adjuvant and neoadjuvant chemotherapies will be permitted if administered more than 6 months before inclusion.
• Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemotherapy.
• All patients must have signed and dated informed consent form.

Exclusion Criteria

• Endocrine or acinar pancreatic carcinoma.
• Patients who progressed during FOLFRINOX regimen.
• Pregnancy or breast feeding.
• Patients with complicated systemic diseases such as diabetes, HTN or decompensated liver disease.
• Patients with any serious uncontrolled medical conditions that might compromise study participation: Central nervous system disorders, gastrointestinal tract disorders that interfere with oral medication.
• Patients with history of previous other carcinoma except basal cell carcinoma of the skin, insitu cervical carcinoma or non-metastatic prostate cancer.
• More than grade 1 peripheral neuropathy.
• Brain metastasis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control arm	follow up	in this arm patients will receive 4 months of FOLFRINOX then kept under follow-up
the maintenance arm	Capecitabine	in this arm patients will receive 4 months of induction FOLFRINOX then maintenance capecitabine

Primary Outcome Measures

Name	Time	Method
PFS	6 months	that will be calculated from the time of randomization till disease progression or death

Secondary Outcome Measures

Name	Time	Method
OS	1 year	that will be calculated from the time of starting of the disease to death (all causes)

Trial Locations

Locations (2)

Nahla Atef Shabaan; 🇪🇬 Cairo, Egypt

Egypt; 🇪🇬 Cairo, Egypt